More researchers are choosing to run decentralized clinical trials (DCTs) over traditional trials. Many of these researchers employ decentralization as a solution to challenges like low enrollment and poor retention.
This patient-centric trial design is considered one of the most effective retention strategies available, enabling participation by people from all backgrounds.
Patient-centric trial design not only helps the trial attract more participants but also improves the results. With a wider and more diverse participant base, more people will be able to benefit from the results in real-world settings.
If you are planning or preparing to execute a decentralized clinical trial that might include ophthalmic endpoints, it is essential to address the needs of sponsors, participants, and other stakeholders.
How can decentralized clinical trial platforms and designs meet these needs? Learn more about decentralized and hybrid trial workflows and what makes them the right clinical trial solutions in many instances.
In decentralized clinical trials, the technology stack enables execution without relying on a fully on-site model. This type of system makes it easier to coordinate on-site and decentralized activities. It allows for maximum oversight and reporting across trial sites, providers, and vendors.
A decentralized clinical trial platform is not a single, standalone solution. Instead, it helps to connect trial partners and various technology tools.
Clinical trials are shifting from solely site-based models to hybrid or decentralized options. DCTs provide the flexibility you and your trial participants deserve, as well as the ongoing support you need for high-quality data collection.
Ophthalmic endpoints are particularly challenging to measure during decentralized trials. Clinical research relies on capturing data from highly sensitive equipment that must be operated by trained technicians.
The environment in which data are gathered must be closely monitored to ensure standardized data collection throughout the trial.
Other types of clinical studies may require only questionnaires or the taking of basic vitals via wearables. Most ophthalmic endpoints, however, cannot be assessed in fully virtual or primarily software-based trials. This is where many DCT strategies fail: the trial design assumes digital convenience can replace controlled clinical conditions. When endpoint integrity depends on calibrated equipment and certified operators, decentralization must be built on a hybrid execution model from day one.
This has to be taken into account from the first phase of planning a decentralized trial. Otherwise, the data you obtain may not be of the quality needed for accurate results and FDA approval. That could jeopardize your trial before it even begins.
When you're dealing with a decentralized clinical trial platform, you must understand just how important technology is.
Technology is the backbone of decentralized and hybrid clinical trials, enabling data management. A specialized technology ecosystem is especially important for centralizing data across various sites and gathering real-time information.
The right system also enables more efficient scheduling, helping reduce missed follow-ups.
At the same time, it supports remote patient monitoring, which improves patient engagement and adherence to the trial requirements. It can lead to better outcomes for participants and protect you from setbacks that could prevent you from accomplishing your mission.
Decentralized and hybrid trial technology offers audit trails that you can rely on during future inspections. It makes oversight much more straightforward, even across distributed activities in hybrid trials. Without these audit trails, it can be much more difficult to ensure that you have actually met all regulatory requirements.
One of the many challenges of hybrid or decentralized trials is gathering all of the acquired data and integrating it into CRO and sponsor workflows. With the right technology, you can streamline this process without overhauling your existing workflows.
For ophthalmic assessments, you will likely need hybrid and point-of-need executions. Generally, these assessments must be performed by certified clinicians. They also require clinical-grade and calibrated equipment. That is not feasible in a fully virtual clinical trial. It would be impossible to preserve data integrity.
The assessments also require a controlled environment. Lighting, patient positioning, and numerous other factors can impact the data. Untrained participants cannot be expected to adhere to these requirements on their own. It would add to the patient burden, potentially leading them to abandon the trial.
Because of these challenges, mobile and on-site delivery models are best suited for ophthalmic assessments. These help maintain the integrity of your datasets.
They also accomplish this without placing further burdens on participants, who would otherwise have to travel to a central site in person for every scheduled check-in.
With a decentralized clinical trial, you can still obtain the reliable data capture you need to meet regulatory requirements.
Patient recruitment doesn't suffer, either, since you can extend participation to people who can't manage frequent travel to the clinical trial site. You can attract more participants overall and include participants from a wider range of socioeconomic backgrounds.
A lack of diversity in the participant base is often a significant challenge for achieving results that apply to real-world settings.
Traditional clinical trials may pose undue burdens on underserved and marginalized populations. The inability to take time off from work to visit the trial site and transportation issues shut many people out of important clinical studies.
Specialized providers that focus on ophthalmic assessments can offer services to support both hybrid and traditional trials. They operate alongside platforms that handle trial data to improve workflows.
With the right service provider, you can rely on the smooth integration of clinical execution and technology to obtain the patient data you need. These elements do not replace each other but instead work seamlessly to deliver real-world results and a better user experience.
With a properly integrated trial model, you can rest assured that all equipment has been calibrated to meet high standards. You'll also rely on trained, certified technicians who are prepared to perform accurate assessments for optimal data collection.
The proper coordination of ophthalmic services and technology is crucial. This ensures that the data gathered from the assessments can be immediately added to the trial's centralized system for review. Otherwise, delays can set your study back. Skewed results and regulatory board questions are additional potential risks.
With a provider that supports integrated workflows, all ophthalmic data will be gathered in central systems for timely review and analysis.
Is the decentralized model appropriate for hybrid, in-person assessments? When planning a clinical trial in therapeutic areas that involve complex ophthalmic assessments, it's vital for sponsors to understand which option best suits their needs.
Some of the most common reasons people require clinical trial rescue services involve difficulties recruiting or retaining participants.
When you're planning a trial with ophthalmic endpoints, a patient-centric, balanced trial design is key. Along with asking participants to travel to the primary site, you must also try to meet them halfway with mobile data capture.
While data quality must come first, monitoring and reporting adverse events are also important. It's necessary to develop strong protocols for reporting these across various trial sites.
Regulatory alignment is essential, too. Reaching out early to the FDA and other bodies for the validation requirements for new remote digital health technologies and other tools can protect your trial. Not using approved technologies would prevent you from obtaining the approvals you need.
Another vital consideration is patient privacy and data protection. All technologies used in hybrid clinical trials must offer end-to-end encryption. Informed consent is another important focus in decentralized trials.
Above all, sponsors and other stakeholders need to assess whether a decentralized trial approach will protect the clinical data. At the same time, the model must be convenient enough to attract more participants than a traditional clinical trial would.
The benefits of decentralized clinical trials are generally significant, making them the right option for many ophthalmic trials.
Ophthalmic endpoints are notoriously difficult to incorporate into fully remote trials. Decentralized clinical trial platforms balance oversight of mobile sites with at-home monitoring.
Decentralization in these trials only works when clinical services and technology are aligned. By offering a balanced trial design that blends flexibility for participants with more controlled assessments, it's possible to obtain quality results.
At 20/20 Onsite, we offer virtual clinical trial tours to help you make the right choice for your next study. We know that sponsors benefit most from trial approaches that combine specialized point-of-need care with centralized oversight. That is why we have made it our goal to support your mission.
You can learn more about what we offer by reading our frequently asked questions. Protect ocular endpoints in decentralized and hybrid trials by scheduling a consultation with 20/20 Onsite's clinical trial ophthalmic services team.